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A Feasibility Study of Adaptive Intensity-Modulated Radiation Therapy in the Definitive Treatment of Head-and-Neck Cancer

Phase 0
18 Years
Not Enrolling
Head and Neck Cancer

Thank you

Trial Information

A Feasibility Study of Adaptive Intensity-Modulated Radiation Therapy in the Definitive Treatment of Head-and-Neck Cancer

In this study, we will plan additional measurements of the position of the patient's organs
weekly during radiation treatment. We will analyze these measurements in order to evaluate
whether we need to adjust our treatment procedures for the remainder of the treatments. We
might adjust the dose of radiation received to specific organs in order to try to minimize
the amount of radiation the healthy tissue receives.

Inclusion Criteria:

- Age >= 18

- Karnofsky Performance Status of >= 60

- New diagnosis of head-and-neck cancer, all subsites included (i.e. nasopharynx,
oropharynx, oral cavity, hypopharynx, larynx.)

- All stages with measurable gross disease (>= 1.0 cm) by CT imaging

- Pathologic confirmation of squamous cell carcinoma by biopsy or cytology

- Signed study-specific consent form

- Sequential or concurrent chemotherapy is allowed but not mandated. (no chemotherapy
is allowed if patient is judged not to be a candidate for chemotherapy by the medical

Exclusion Criteria

- Age < 18

- Karnofsky Performance Status < 60

- Radiographic or pathologic evidence of distant metastatic disease (i.e. other than
cervical lymph nodes)

- Prior radiation therapy to the head-and-neck region

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Feasibility of adaptive radiation therapy in the definitive treatment (MLC-based IMRT or helical tomotherapy)

Outcome Description:

Feasibility is determined by employing weekly 3D onboard imaging for plan re-evaluation and initiation of an adaptive process if the original PTV and/or normal structure goals are compromised.

Outcome Time Frame:

7 weeks

Safety Issue:


Principal Investigator

Wade Thorstad, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine


United States: Institutional Review Board

Study ID:




Start Date:

January 2007

Completion Date:

January 2008

Related Keywords:

  • Head and Neck Cancer
  • Newly Diagnosed head and neck cancer
  • Head and Neck Neoplasms



Washington University School of MedicineSaint Louis, Missouri  63110